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|
| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P930016 S053/ PAS001 |
| Date Original Protocol Accepted |
01/29/2019
|
| Date Current Protocol Accepted |
02/26/2021
|
| Study Name |
STAR-122-MVPM Post-Approval Study
|
| Device Name |
iDESIGNRefractive Studio, STAR Excimer Laser System
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
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| Comparison Group |
Device Subjects Serve as Own Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This study is a multi-center, single-arm, prospective post-approval study in which each subject’s preoperative status is serving as the control for post-surgical outcomes. The study is observational in nature.
|
| Study Population |
This study will include only subjects undergoing monovision Lasik treatment and who meet all of the study inclusion and exclusion criteria in both eyes. All subjects who meet the inclusion/exclusion criteria will be offered treatment in the study.
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| Sample Size |
The study will enroll 383 subjects who have stable myopic refractive error with presbyopia from 8 to 14 sites/investigators across different US geographies. Assuming no more than 30% screen failures and 10% of attrition rate, approximately 268 subjects are to be treated to ensure 241 subjects evaluable at 12 months of follow up.
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| Key Study Endpoints |
The study will evaluate: Demographic information, preoperative monovision screening, uncorrected and best corrected vision (monocular and binocular) at distance and near, manifest refraction, and the PROWL scores. All endpoints will be evaluated at preoperative visit and at the postoperative 12-Month visit. The specific endpoints include:
Co-Primary Study Endpoint:
¿Change in driving scale score from preoperative to postoperative as measured by the driving scale within PROWL.
¿The proportion of subjects who required secondary surgery to reverse monovision
Secondary Study Endpoints:
¿The proportion of subjects who experienced bothersome visual symptoms (e.g.,halo, glare, starburst, double images)
¿The proportion of subjects who experienced ‘Moderate to Severe Difficulty with Activities’
¿The proportion of subjects with ‘Satisfaction with Vision’ as measured by PROWL
¿The proportion of subjects with ‘Satisfaction with Surgery’ as measured by PROWL
¿The proportion of subjects who achieve 20/40 or better uncorrected distance and near vision
Exploratory Study Endpoints:
¿The proportion of subjects whose driving scale within PROWL score increases or decreases by more than 8 points from preoperative visit.
¿The proportion of subjects who experience visual symptoms that are severe enough to limit usual activities after undergoing monovision LASIK treatment
¿Baseline subject characteristics associated with difficulties with driving (based on driving scale score) and/or visual symptoms
Other Study Endpoints:
¿UCDVA, monocular (all treated dominant eyes)
¿UCNVA, monocular (all treated eyes)
¿UCIVA, binocular (subjects)
¿BSCVA, monocular (all treated eyes)
¿Depth perception, binocular (subjects)
¿Manifest refraction (all treated eyes)
¿Non-directed visual symptoms
¿Mean change from baseline in visual symptoms via the PROWL questionnaire
¿Adverse event type and rates
|
| Follow-up Visits and Length of Follow-up |
Eligible subjects who are enrolled in the study will be followed for 12 months, with the frequency of assessments
Preoperative (Within 120 to 14 days prior to surgery)
Operative Day
Postoperative 1 day, 1 week, and 1, 3, 6, 12 months
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
204 enrolled, 142 treated
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| Actual Number of Sites Enrolled |
8 enrolled
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